Host-pathogen Interactions in Meningococcal Disease: Finding the Key That Fits the Lock

Meningitis Clinical Trial

— Lock and Key  

Official title:

Host-pathogen Interactions in Meningococcal Disease: Finding the Key That Fits the Lock

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02727465
• Other study ID #: Lock and Key
• Status: Withdrawn
• Phase: N/A
• First received: March 9, 2016
• Last updated: April 3, 2017
• Start date: March 2016
• Est. completion date: December 2019

Study information

• Verified date: April 2017
• Source: Public Health England
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

At any time, around 10% of people carry meningococcal bacteria in the nose and throat, which can cause meningitis, blood poisoning and other serious illnesses. Most people carry these bacteria and never become ill, yet a very small proportion go on to develop these illnesses which can result in life long disabilities or death. The mechanism by which this happens is poorly understood and has been studied in various ways, usually focussing on the bacteria or on the individual, but none has given a definitive answer. This study will be the first of its kind and will assess the interaction between the host and the bacteria at the genetic level, through genetic mapping, helping us to understand what makes some people susceptible to this infection.

Description:

At any time, around 10% of people carry meningococcal bacteria in the nose and throat, which can cause meningitis, blood poisoning and other serious illnesses. Most people carry these bacteria and never become ill, yet a very small proportion go on to develop these illnesses which can result in life long disabilities or death. The mechanism by which this happens is poorly understood and has been studied in various ways, usually focussing on the bacteria or on the individual, but none has given a definitive answer. This study will be the first of its kind and will assess the interaction between the host and the bacteria at the genetic level, through genetic mapping, helping us to understand what makes some people susceptible to this infection.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• any individual with culture-confirmed IMD in England from 01 September 2015 to 31 August 2019

• written informed consent from the individual, the parent (for children aged <16 years) or next-of-kin (for non-survivors)

Exclusion Criteria:

• any individual who does not fulfil the inclusion criteria

Temporary Exclusion Criteria:

• Critically-ill patients and/or their family member will be only approached when the patient starts recovering from their illness or after they are deceased, on the advice of their clinical team.

Related Conditions & MeSH terms

• Meningitis
• Meningococcal Infections

Intervention

Other:
• Meningitis cases
None - blood draw only

Locations

Country	Name	City	State
United Kingdom	All NHS hospitals	England

Sponsors (1)

Lead Sponsor	Collaborator
Public Health England

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	informed consent obtained for all culture-confirmed IMD to sequence their genome.	enrol cases	up to 55 months
Secondary	creation of a functional database linking anonymised whole genome human and meningococcal sequences with data collected through national surveillance	construction of reference database	up to 55 months
Secondary	detailed genetic analysis on human-pathogen pairs, focussing particularly on (but not restricted to) the human complement system and the respective meningococcal binding proteins.	Genetic analysis	up to 55 months
Secondary	visualising potential host-pathogen interactions through computer modelling	computer modelling	up to 55 months